FDA Update: Kadcyla approved and more drug news


The new therapy Kadcyla (ado-trastuzumab emtansine) has been approved under the FDA's priority review program for use in persons with HER2-positive, metastatic breast cancer who previously received the anti-HER2 therapy trastuzumab and taxanes. 


The FDA has expanded the approved use of Stivarga (regorafenib) to the treatment of advanced gastrointestinal stromal tumors (GIST) that cannot be resected or that have metastasized and no longer respond to imatinib or sunitinib
.

Pomalidomide (Pomalyst) is approved by the FDA for the treatment of advanced multiple myeloma in persons who received at least two prior therapies and have demonstrated disease progression on or within 60 days of completion of the last therapy. Pomalidomide is contraindicated during pregnancy and can cause blood clots.


Lymphoseek (technetium Tc99m tilmanocept) Injection, a radioactive diagnostic imaging agent, has been approved by the FDA to help clinicians locate lymph nodes in persons with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. 


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